MX2007009179A - Surgical fastener buttress materials. - Google Patents

Abstract

A staple line buttress material having an adhesive surface, packaged and provided in sterile, ready-to-use form. The material can be used to retrofit surgical staplers to provide an improved staple line, and with improved ease of use.

Description

SUPPORT MATERIALS OF SURGICAL CLIPFIELD OF THE INVENTION The invention relates to a surgical fastener, and to reinforcement materials adapted to be used in combination with surgical fasteners.

BACKGROUND OF THE INVENTION Surgical fasteners are commonly used in surgeries to perform a variety of functions, for example to remove parts of organs (eg, to resect tissues) to cut through organs and tissues (transection), and to create connections between structures (to create anastomas). A variety of surgical fasteners are currently in use and include staple applicators, surgical staplers and other devices. Surgical staplers are commonly used in a variety of surgical procedures including vascular, bariatric, urological, gynecological, thoracic and pediatric surgeries. For example, a thoracic procedure is a reduction in the volume of the lung, which resects a portion of the lung to treat emphysema or other conditions. Also, a bariatric procedure is the gastric bypass procedure, which resects a portion of the stomach to create a smaller stomach forHelp weight loss. Surgical staplers are also provided in many forms, including linear staplers, circular staplers and contoured or curved staplers. Surgical staplers commonly include a pair of opposing work surfaces. In the case of a linear stapler, two opposed jaws are provided, one containing a staple cartridge and the other being an anvil member against which the staples are fired. When the stapler is activated or triggered, it simultaneously emits a plurality of rows of staples closely spaced from the cartridge, and through the tissue of the patient himself. In some cases leaks of and / or fluid and / or excessive bleeding have been reported in the staple line. The term "staple line" is used herein to refer to any staple fabric row, and the staple line may be linear, circular or curved, depending on the type of stapler used. Leaks can occur in the cut line, and / or in the staple holes themselves. Frequently in the case of thoracic procedures, the diseased lung tissue is thin and fragile and can tear in the staples when the lung is reinflated. Air leaks can be persistent and can extend a patient's hospital stay for weeks. As means to alleviate thoseWith leakage problems, surgeons often reinforce the stapling line by applying a reinforcement material or compress to the desired stapling site, and stapling through the reinforcement material. The reinforcing material provides reinforcement to the frangible fabric, since it reduces the tearing changes of the fabric in the staple line, and reduces the disengagement of the staple in the brittle tissue. The reinforcement material also creates a stronger staple line to increase safety against air leaks and / or fluid and / or excessive bleeding during surgery in the next crucial weeks. A variety of materials have been described for use as reinforcing materials for the staple line, including those formed of specially formed tissue (eg, bovine pericardial tissue), alginate, polyglycolic felt, and Teflon yarn materials, however a Handful has been found suitable for commercial use. These reinforcing materials are typically removably mounted on the working surface of a surgical stapler so that after firing or activation, the patient's tissue is related between the strips of the reinforcement material. The reinforcing materials are typically mounted, releasably, on the working surfaces of a surgical stapler by mechanical meansand / or chemicals. In some cases, an adhesive is applied to one or both surfaces of the stapler itself, or to a surface of a strip of reinforcing material, and the strip is then applied to the corresponding work surface. For example, in the case of linear staplers, the reinforcing material is often bonded with an adhesive to each opposite jaw. Current adhesives are typically biocompatible gels which are applied to the reinforcing material itself to hydrate the material and to create a temporary bond between the material and the stapler. In many cases, it is generally necessary to properly align and position the strip of reinforcement material on the work surfaces of the stapler. Improperly aligned reinforcement material often results in a failed staple line. Devices have been developed that include an alignment feature to assist a user in properly aligning a reinforcement material on the work surfaces of a stapler. For example, that apparatus is described in U.S. Patent Application No. 5,752,965, all of the content of which is incorporated herein by reference.

SUMMARY OF THE INVENTION The invention provides a reinforcing materialimproved. Current methods for placing the reinforcement material on the work surface of the stapler typically involve at least two steps, one step of applying the adhesive material to the reinforcement material (or to the working surface of the surgical stapler) and then applying the reinforcement material to the work surface. The invention makes possible a one-step method of applying a reinforcing material to a work surface of a stapler. Also, current methods of aligning the reinforcement material on the work surface of a stapler are not fail-safe, even with the use of alignment devices. Often, when a user applies an adhesive to either the reinforcement material or the working surface of the stapler, too much adhesive is applied. This excess adhesive often causes the work surface to become slippery and the reinforcing material to slide along the surface and become misaligned. Thus, the invention also provides a method for applying a reinforcing material on a work surface of a stapler that substantially reduces the invention resulting from poor application of the adhesive by the user.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view showingan article of a reinforcing material according to one embodiment of the invention. Figure 2 is a perspective view showing the coupling method between a surgical stapler and two articles of reinforcement material according to an embodiment of the invention. Figure 3a is a partial exploded view of an alignment apparatus adapted to incorporate two articles of reinforcement material according to one embodiment of the invention. Figure 3b is a cross-sectional view of an apparatus of Figure 3a along line 3B-3B. Figure 4a is a perspective view showing the coupling method between a surgical stapler and an alignment apparatus incorporating two particles of reinforcement material according to one embodiment of the invention. Figure 4b is a cross-sectional view of the apparatus of Figure 4a taken along line 4B-4B.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES In some embodiments, the invention provides a suture line reinforcing material having at least one adhesive surface, the material being packaged and provided in a form that allows the surface to belined with and releasably covered by the work surface of a surgical fastener. The term "suture line" is used herein to refer to any row of sutured tissue. The suture line can be sutured using staples, clamps or the like. Also, the suture line can be linear, circular, curved or of any other suitable pattern or design depending on the type of surgical fastener used. The reinforcing material is adapted for use with any surgical fastener known in the art. In known embodiments, the surgical fastener preferably comprises a surgical stapler, and more preferably, comprises a linear stapler. The reinforcing materials are often provided in the form of a strip or other configuration where there are two larger surfaces, a surface adapted to come into contact with a working surface of a surgical fastener and another surface adapted to be placed against the tissue body. . The adhesive surface of the reinforcing material is provided on a surface that will come into contact with the working surface of the surgical fastener. The adhesive is also sufficiently adhesive to allow the material, preferably without extraneous means such as removable sleeves, chains or aggregate gels, to be retained on the working surface of the surgical fastener in the courseof the placement of the surgical fastener inside the surgical site, and then they are removed from the work surface after the application of the surgical fastener. Reinforcing materials having at least one adhesive surface provide several advantages including the ability to avoid the need for a separate step for applying an adhesive gel. This improves the ease of use of loading the reinforcement material within the surgical fastener because the currently used two-step loading processes are now converted to a one-step loading process. In addition, this elimination of the second step helps to reduce misalignment of the adhesive. The reinforcing material having at least one adhesive surface may be comprised of a single material or a composite of two or more of the same or different materials. In preferred embodiments, the reinforcing material includes at least one material that has sufficient mechanical strength to reinforce a suture line (hereinafter "reinforcement material"). The composition of the materials can be provided with a sheet of materials, a homogeneous mixture of materials, a graduated mixture of materials or other suitable formations. The reinforcing material can also be formed from synthetic or natural fabric. In certain embodiments, the reinforcement material is formed from natural animal tissue. InIn some cases, the natural animal tissue is a fibrous or waxy membrane. In preferred cases, the natural animal tissue is a fibroserous membrane comprising pericardium, preferably bovine pericardium. In some embodiments, the natural animal tissue may be a fabric of the type described in any of our US Patent Applications Nos. 5,503,638, 5,575,803, 5,549,628, 6,468,313, 6,312,474 and 6,652,594, the entire contents of each of which is incorporated herein by reference. reference. In particularly preferred cases, the reinforcing material comprises treated bovine pericardium available from the beneficiary of the application and sold under its trade name Peri-Strips Dry®. The use of this particular type of material is advantageous since it has a much higher density of collagen than most other connective tissues and is cross-linked with glutaraldehyde. The high density of the bovine pericardium provides greater structural integrity around the suture line and cross-linking with glutaraldehyde is advantageous since it increases the antigenicity of the tissue, thereby resulting in little or no region of inflammation with the attached body tissue. In another preferred embodiment of the invention, the reinforcing material comprises treated bovine pericardium available from the applicant's beneficiary and soldunder its trade name Veritas®. Although the preferred embodiment of the present invention employs bovine pericardium as the reinforcing material, it is readily understandable that other hard or suitable pericardium material may be employed, including but not limited to equine, porcine, bovine and human as well as synthetic biocompatible materials. In a preferred embodiment of the present invention, the reinforcing material comprises a smooth, dense, non-porous membrane. A cross-linked bovine pericardium fabric, for example the Peri-Strips Dry® material, is an example of that dense membrane. In other embodiments, the reinforcing material resists or substantially resists in-vivo degradation. For example, that reinforcing material preferably undergoes little or no hydrolysis once in contact with body fluids or saline. The cross-linked bovine pericardium, for example, the Peri-Strips Dry® material is also an example of a material which resists in-vivo degradation. In other cases, a removable material is provided which is integrated into the surrounding body tissue over time. Preferably, the remodelable material comprises non-crosslinked animal tissue, for example bovine pericardium. The Veritas® material is an example of that remouldable material. In additional modalities, the reinforcement materialexhibits superior tensile strength, resistance to leakage and resistance to breakage. For example, the material preferably has a pre-implant tensile strength where the peak load is at least about 2000 grams, more preferably at least about 3000 grams and optimally at least about 4000 grams. In other cases, the material has a pre-implant tensile strength which does not decrease significantly with time once implanted in vivo. The pre-implant tensile strength of a material can be measured using a MTS Q45 uniaxial tensile tester. The reinforcing material also preferably has a leakage pressure of at least about 90 mm Hg, more preferably at least about 150 mm Hg. In other embodiments, the reinforcing material has a rupture pressure of at least about 90 mm Hg, more preferably at least about 150 mm Hg, and optimally, at least about 200 mm Hg. The leakage pressure and the rupture pressure can be measured by introducing blue dye on the suture line at a constant speed and then introducing pressure. Leakage pressure is the pressure at which blue dye leakage is observed through the suture line. The rupture pressure is recorded when the pressure reaches a plateau or drops abruptly when the line ofsuture bursts. The cross-linked bovine pericardium, for example, Peri-Strips Dry® material is also an example of a material that exhibits superior tensile strength, leak resistance and breaking strength. The reinforcing material can be provided with an adhesive surface in a variety of ways. In some embodiments, the reinforcing material includes a single material that has adhesive properties by itself. The individual material also preferably has sufficient mechanical strength to reinforce a suture line. For example, a microgel film can be provided as the individual material, where the hydrogel is provided with sufficient mechanical strength. In this case, any surface of reinforcing material could be provided as an adhesive surface in contact with a work surface of a surgical fastener. In other embodiments, the adhesive material is pre-applied onto a surface of reinforcing material (which may include a single material or a composite of one or more materials). In those cases, one or more materials comprising reinforcing material generally have reinforcement and strengthening properties rather than adhesive properties, since a separate adhesive is previously applied to a surface. However, this does not mean that one or more materials that can becertainly include a material that has adhesive properties. In this case, the surface of the reinforcement containing the previously applied adhesive is provided as the adhesive surface. The adhesive material is preferably formed on a surface via a layer or film, although other configurations are also possible. The adhesive can be pre-applied on one or more surfaces of the reinforcing material according to any methods known in the art using conventional coating equipment and materials. Suitable coating methods include, for example, air knife, brush, calender, cast, curtain, dipping, extrusion, blade, blade, engraving, die, blade on blanket, blade on roller, transfer engraving, reverse roller, roller Inverse smooth, rod, roclos, compression roller, in vivo polymerization and spray resin coating. In turn, the coated material may be in any suitable form, for example, in the form of a pulverized resin composition, water-based or solvent based grout, emulsion or dispersion. The adhesive can be applied to a surface, two or more surfaces, or to all surfaces of the reinforcing material. In cases where the reinforcement material is porous or can be saturated otherwise, the adhesive maybe applied to saturate all the reinforcement. Preferably the hydrogel is applied to only one side with the opposite side leaving uncoated or treated or provided itself with a suitable coating or properties. The adhesive is preferably applied to one or more surfaces as a thin layer, for example, between about 0.1 mm and about 1.0 mm nominal thickness, and more preferably between about 0.25 mm and about 0.75 mm nominal thickness. A variety of materials can be provided as the adhesive material. In preferred embodiments, the adhesive material comprises a biocompatible gel. In particularly preferred embodiments, the adhesive material comprises a hydrogel, which can also be described as a polymer gel containing water. Suitable hydrogels include those based on natural hydrogels(for example, artificial silk, cellulose materials) and synthetic hydrogels, such as methacrylic and acrylic esters, acrylamide hydrogels, hydrogels based on N-vinyl-2-pyrrolidone, and polyelectrolyte complexes and charged hydrogels, including combinations, mixtures and copolymers of the same. The inventors have discovered that suitable hydrogels provide an optimum combination of properties such as adhesion to the reinforcing material of choice, adhesion to the working surfaces of a surgical fastener,flexibility, contour formation, biocompatibility, biostability and the ability to be sterilized. Examples of suitable hydrogels include those available under the trademark of Aquatri • x IIMRof Hydromer, Inc., a limited company located in Branchburg, New Jersey. In a particularly preferred embodiment, the hydrogel comprises poly (N-vinyl lactam) -cytosan gel. Gels such as those described in U.S. Patent Nos. 6,379,702, 6,365,664, 6,121,375, 5,420,197, 5,258,421 and 5,156,601, all of which are incorporated herein by reference. Chitosan is a deacetylated chitin, and is a linear polysaccharide of N-acetyl-D-glucosamine deacetylated. Poly (N-vinyl lactam) such as polyvinylpyrrolidone (PVP) has been used in drugs, in certain types of films, and in some cosmetic products. They can be used to provide dermatologically compatible gels having a hydrophilic absorbent property and K values of less than 60. Those materials are preferably stable, hydrophilic gels which comprise a combination of acid-neutralized chitosan and a poly (N-vinyl lactam) ) with or without a plasticizer, the poly (N-vinyl lactam) having a K value of less than about 60 and molar equivalents of acid groups of at least about 1.4.

These preferred gels can be prepared by mixing aqueous poly (N-vinyl lactam) solution and acid-neutralized chitosan in aqueous solution at a weight ratio of poly (N-vinyl lactam) / chitosan of about 12/1 to about 1/1 , preferably from about 10/1 to about 5/1, to form a combination of about 5% by weight to 40% by weight of total polymer concentration, preferably from about 12.5% by weight to about 25% by weight of polymer concentration, and allowing the combination to cure until a gel forms. In some embodiments, the adhesive surface has a predetermined adhesive strength or adhesion, the predetermined adhesive force being reduced when the adhesive surface is hydrated. The terms "adherent" and "adhesive strength" are used herein to describe the adhesiveness of the adhesive. Adhesion of an adhesive is typically the tensile strength (measured in dynes) exerted by the adhesive fully adhered to two surfaces that are separated. The higher the tensile strength, the greater the adhesion of the adhesive. Thus, when the adhesive material is outside the body and in a dry form, it has sufficient adhesion to prevent the reinforcing material from being removed or realigned along the working surfaces of the surgical fastener. WithoutHowever, when the reinforcement material is placed in vivo where it comes into contact with tissue and body fluids, it is hydrated and this causes the surface to be easily removed from the work surfaces of the surgical fastener. Therefore, in preferred cases, the adhesive surface is packaged and provided in such a way that it has sufficient adhesion to be applied securely to a work surface of a surgical fastener, this adhesion being reduced when the adhesive surface is placed inside the surgical site In preferred embodiments, the adhesive material of this invention can be used to provide one or more bioactive agents, including locally at the placement site, or more broadly, including systemically through the patient. These bioactive agents can serve to improve the function of the adhesive itself and / or can serve related or unrelated functions within the body. In some embodiments, for example, the adhesive can be used to a large extent as the bioactive release device, with its function as a reinforcing material being auxiliary thereto. In preferred cases, one or two bioactive agents are provided which would improve the healing of the stapled tissue or otherwise sutured. Examples of suitable bioactive healing agents include, but are not limited to antibiotics, anti-inflammatory agents, factorsof growth and cytokines. Coagulants may also be provided to reduce bleeding and radioactive agents may be provided to provide verification of the location of the reinforcement material within the body. In some embodiments, the invention also provides surgical combinations, which include a reinforcement material according to any of the embodiments already described. For example, in some cases, a combination that includes a surgical fastener and at least one article of reinforcement material may be provided. Any surgical fastener known in the art can be used with this combination. In preferred embodiments, the surgical fastener preferably comprises a surgical stapler, and more preferably comprises a linear stapler. In other cases, a combination including an apparatus for equipping a surgical fastener with a reinforcing material and at least one article of reinforcement material is provided. Suitable apparatuses for equipping a surgical fastener with a reinforcing material are described in U.S. Patent Nos. 5,752,965 and 6,656,193 and in U.S. Publications Nos. 20040093029, 20030120284 and 20020165563, all the contents of each of which is incorporated herein by reference. reference. These devices are useful to provide one or more items of a reinforcement materialin a releasable union with working surfaces of a surgical fastener so that the articles are automatically coated with those surfaces. At least one article of reinforcement material may be provided installed within a reinforcing material or with a separate component that is part of a surgical equipment in which the reinforcing material is inserted into the apparatus at the surgical site. In certain embodiments, the invention provides surgical methods of using the reinforcement material. The reinforcing material of the invention can be used in a variety of surgeries, including vascular, bariatric, urological, gynecological, thoracic and pediatric surgeries. Common bariatric surgeries include gastric bypass and gastric bending. Gastric bypass surgeries also include the following types of surgeries: roux-on-gastric surgery (RYGB), vertical-band gastroplasty, and biliopancreatic diversion. Common thoracic surgeries include blebectomies, bulectomies, wedge resections, segmentectomies, lobectomies, pneumonectomy, volume reduction surgery of the lung, and other resections of the lung and bronchi. The surgical method of the invention generally includes providing one or more articles of reinforcement material to a work surface of a fastenerSurgical, place the surgical fastener around a section of body tissue, and apply the fastener to form a reinforced suture line. In cases where the adhesive material loses adhesive strength when hydrated in vi, it is desirable to place the surgical fastener around a section of body tissue for a sufficiently long period of time to hydrate the adhesive material so that the articles of reinforcement material are easily released from the work surfaces of the surgical fastener. The use of a reinforcing material of this invention will now be described with respect to a preferred embodiment of the invention, which is illustrated by means of the figures. Figure 1 illustrates an article of reinforcement material 100 having a layer of adhesive material 105 previously applied on a surface 103 of reinforcing material 108. Adhesive material 105 comprises any suitable adhesive material and reinforcing material 108 comprises any material of adequate reinforcement. The reinforcing material 100 is dimensioned and configured to be placed and aligned on a linear stapler jaw, with the surface 103 containing the adhesive 105 being in direct contact with the surface of the jaw. Figure 2 illustrates a generic linear surgical stapler 46 having a jaw supporting astaple cartridge 48 and a jaw supporting an anvil 50 extending from a two-part handle, which in turn includes a moving part 52 and a stationary part 54 which is rotatably and removably articulated at 56 to the mobile part. The jaw supporting the cartridge 48 contains a cartridge body (not shown) containing a plurality of staples placed in rows oriented longitudinally to the jaw 48 in opposition to an anvil (not shown) supported by the jaw 50 when the members 48 and 50 are in their closed position. Two articles of reinforcing material 100a and 100b are provided in size and shape to be mounted on the working surfaces of the parts 52 and 54 of the surgical device 46. As illustrated, the article 100a is positioned so that its layer of adhesive material previously applied 105 is oriented upward to adhere to the working surface of the jaw supporting cartridge 48. Similarly, article 100b is positioned so that its layer of pre-applied adhesive material 105 is oriented downward to adhere to the working surface of the jaw supporting the anvil 50. Figures 3a-3b show an apparatus 10 for equipping a surgical fastener with a reinforcing material. The apparatus is adapted to incorporate articles of reinforcement material 100a and 100b according to a modalityparticularly preferred. In this embodiment, the apparatus 10 is configured to be used with a linear stapler. Referring collectively to Figures 3a-3b, the apparatus 10 includes an alignment frame 18 and an internally positioned pressure equalizing member 20. The alignment frame 18 can be configured in any way to stop articles 100a and 100b of material from reinforcement in a releasable ion within the alignment frame 18 so that the articles 100a and 100b are automatically aligned with the opposite jaw members of the linear stapler. In the illustrated embodiment, the alignment frame 18 includes a generally planar liner portion 22, a first guide channel 24 and a second guide channel 26. The liner portion 22 includes an internally located receiving area 40. The equalizing member Pressure 20 is positioned internally within the receiving area 40 and is preferably constructed of a deformable and elastic substrate, such as foamed plastic, rubber and / or any of a number of suitable materials having similar properties. By providing that uniform distribution of pressure, the pressure equalizing member 20 ensures that the articles 100a and 100b conform more easily to the shape and contour of the opposing work surfaces during the closing step of the surgical stapler around the apparatus 10. The elasticity of the pressure equalizing member20 is also advantageous since it serves to deflect releasably the articles 100a and 100b within the receiving area 40 of the alignment frame 18. The first guide channel 24 and the second guide channel 26 are sized to regulate the engagement of the surfaces of opposing work of a surgical stapler and the alignment apparatus. The articles 100a and 100b are designed to be placed within the reception area 40 to be generally in line with the first and second guide channels 24, 26, respectively. The guide channels 24, 26 will automatically direct the opposing jaws of a surgical stapler in contact with the adhesive surface 105 of each reinforcement material 100a and 100b when the surgical stapler is lowered onto the apparatus 100. Referring now to FIGS. 4a and 4b , apparatus 10 is shown fully enabled for use with a surgical stapler 46. In this embodiment, a combination including articles of reinforcement materials, articles 100a and 100b and apparatus 10 for equipping a surgical fastener with a material is provided. of reinforcement. The apparatus 10 of this embodiment includes an alignment frame 18, a first article of reinforcement material 100a and a second article of reinforcement material 100b. The articles 100a and 100b are placed in areleasable within the reception area 40 to generally align with the first and second guide channels 24, 26, respectively. To equip a surgical stapler to produce the reinforcement staple line, the opposing work surfaces of the surgical stapler are placed within the first and second guide channels 24, 26, respectively, and held in contact with the adhesive layers 105 of the articles. 100a and 100b. The surgical stapler is held in this closed position for a given period of time and then detached from the alignment frame 18 to remove the pressure equalization means 20, together with the reinforcement material articles 100a and 100b from within the receiving area. 40. The adhesive layer 105 forms a sufficient bond between the articles 100a and 100b and the opposing work surfaces of the surgical stapler so that, when the surgical stapler is opened from the previously held position, the articles 100a and 100b remain joined together. releasable manner to the opposing work surfaces of the surgical stapler and the pressure equalizing member 20 can be removed from between the articles 100a and 100b. The surgical stapler is then fully equipped with the articles 100a and 100b, so that the opposing work surfaces thereof can be placed aroundof a section of body tissue to form a reinforced staple line according to the present invention. Although a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (1)

1. CLAIMS Having described the invention as above, the content of the following claims is claimed as property. A surgical fastener reinforcing material having an adhesive surface, characterized in that the material is packaged and is provided in a shape that allows the adhesive surface to be aligned with a releasable cover of a work surface of a surgical fastener. The material according to claim 1, characterized in that the reinforcing material is packaged and provided in such a way that it allows the adhesive surface to be aligned with a releasable cover of a work surface of a surgical fastener in a loading process one step 3. The material according to claim 1, characterized in that the adhesive surface has a sufficient adhesive force to allow the material, without foreign means, to be retained on the working surface of the surgical fastener in the course in which the surgical fastener is placed inside the surgical site, and then removed from the work surface after the application of the surgical fastener. . The material in accordance with the claim 1, characterized in that the adhesive surface has a predetermined adhesive force when it is retained on the working surface of a surgical fastener, the adhesive force being reduced when the adhesive surface is placed and hydrated in vi. 5. The material according to claim 1, characterized in that the adhesive surface is a surface comprising a previously applied adhesive material. 6. The material according to claim 5, characterized in that the previously applied adhesive material comprises a previously applied hydrogel. The material according to claim 6, characterized in that the previously applied adhesive material further includes one or more bioactive agents. The material according to claim 1, characterized in that the reinforcing material includes at least one reinforcing material having sufficient mechanical strength to reinforce a suture line of surgical fastener. 9. The material according to claim 8, characterized in that the reinforcing material includes a composition of two or more materials, at least one of the materials being a reinforcing material. 10. The material according to claim 8, characterized in that at least one reinforcing material substantially resists degradation when implanted in vivo. The material according to claim 8, characterized in that at least one reinforcing material has a pre-implant tensile strength having a peak load of at least about 2000 grams. 12. The material according to claim 8, characterized in that at least one reinforcing material has a pre-implant tensile strength which does not decrease significantly with time when implanted in vivo. The material according to claim 8, characterized in that at least one reinforcing material has a leakage pressure or rupture pressure of at least about 90 mm Hg. The material according to claim 8, characterized in that at least one reinforcing material comprises a natural animal tissue. 15. The material according to claim 14, characterized in that the animal tissue natural comprises a fibroserous or serosa membrane. 16. The material according to claim 15, characterized in that the natural animal tissue comprises a fibroserous membrane comprising bovine pericardium. The material according to claim 8, characterized in that at least one reinforcing material also has a sufficient adhesive force to allow the material, without foreign means, is retained on the work surface of the surgical fastener in the course in which the surgical fastener is placed inside the surgical site, and then be removed from the work surface after application of the surgical fastener. 18. A combination, characterized in that it comprises a surgical fastener having at least one work surface and a reinforcement material according to claim 1, placed on at least one work surface. 19. The combination according to claim 18, characterized in that the surgical fastener comprises a surgical stapler. 20. The apparatus for facilitating the alignment and application of a reinforcement material to a work surface of a surgical fastener, the device is characterized in that it incorporates a reinforcement material according to claim 1. 21. The apparatus according to claim 20, characterized in that it further comprises an alignment frame which retains one or more articles of the reinforcement material in releasable connection with the frame. of alignment, so that one or more articles are automatically aligned with opposite work surfaces of a surgical fastener. 22. A surgical equipment for facilitating the application of an article of reinforcement material to the opposing work surfaces of a surgical fastener, characterized in that the equipment includes one or more articles of the reinforcement material according to claim 1 and an apparatus for alignment. 23. The surgical equipment according to claim 22, characterized in that one or more articles of reinforcement material are adapted to be loaded in the alignment apparatus. 24. A surgical method, characterized in that it comprises the steps of: providing one or more articles of the reinforcement material according to claim 1; applying one or more articles of reinforcement material to a work surface of a surgical fastener; placing the surgical fastener around a section of body tissue; and apply the bra to apply a reinforced suture line. 25. The surgical method according to claim 24, characterized in that the step of placing a surgical fastener comprises placing the surgical fastener around a section of body tissue for a prolonged period of time sufficient to hydrate the adhesive surface. 26. The surgical method according to claim 24, characterized in that the step of applying a fastener comprises applying the fastener once on the adhesive surface that has been hydrated. 27. The surgical method according to claim 24, characterized in that the method is adapted for use in a surgical procedure selected from the group consisting of vascular, bariatric, urological, gynecological, thoracic and pediatric surgery. The surgical method according to claim 27, characterized in that the method is adapted for use in a bariatric surgical procedure selected from the group consisting of gastric deviation of roux in y, vertical band gastroplasty, and biliopancreatic fun. 29. The surgical method according to claim 27, characterized in that the method is adapted for use in a thoracic surgical procedure selected from the group consisting of blebectomies, bulectomies, wedge resections, segmentectomies, lobectomies, pneumonectomy, lung volume reduction surgery , and other resections of the lung and bronchi.